Biliary Tract Carcinoma
Conditions
Brief summary
Overall Survival (OS)
Detailed description
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCISPLATIN
DRUGGEMCITABINE
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR), Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | — |
Countries
Belgium, France, Germany, Ireland, Italy, Netherlands, Spain
Outcome results
None listed